(93 days)
Not Found
No
The description focuses on the physical components and operational steps of an X-ray irradiator, with no mention of AI or ML technologies.
Yes
The device is described as an X-ray Blood Irradiator intended for medical purposes, specifically to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease and to assist in the prevention of metastasis in cancer patients. These are therapeutic applications.
No
The device is an irradiator used to inactivate T-lymphocytes and prevent metastasis, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines hardware components such as a shielded cabinet, x-ray tubes, power supplies, and an operator control panel. It is a physical device that performs irradiation.
Based on the provided information, the Raycell X-ray Blood Irradiator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Raycell irradiates blood and blood products in transfusion bags and intra-operatively salvaged blood. While this blood originates from a human, the device is acting on the blood outside of the body for therapeutic purposes (preventing Graft Versus Host Disease and assisting in preventing metastasis), not for diagnostic testing or analysis of the specimen itself.
- The intended use is therapeutic/preventative. The purpose is to inactivate T-lymphocytes and potentially prevent metastasis, which are therapeutic or preventative actions, not diagnostic ones.
- The device description focuses on irradiation technology. The description details the X-ray tubes, shielding, and control panel, all related to the physical process of irradiation, not to analyzing or testing the blood.
Therefore, the Raycell X-ray Blood Irradiator falls under the category of a therapeutic or preventative medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease according to applicable FDA, AABB, Health Canada, and European guidelines.
The Raycell X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.
Product codes
MOT
Device Description
The Raycell is a self-contained shielded cabinet X-Ray Blood Irradiator. The device consists of a lead shielded chamber containing two vertically opposed x-ray tubes with provision for a sample canister holder between them, dual power supplies and a operator control panel. The operator places the blood products to be irradiated in the canister, opens the drawer, places the canister in the holder, closes the drawer and starts the irradiation cycle at the Operator Panel. The design of this device is substantially equivalent to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment. Validation testing demonstrated that the device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 12, 2016
Best Theratronics Limited % Mr. Mike de van der Schueren Quality & Regulatory Manager 413 March Road Ottawa, Ontario K2K 0E4 CANADA
Re: K161324 Trade/Device Name: Raycell Mk2 Regulation Number: None Regulatory Class: Unclassified Product Code: MOT Dated: August 4. 2016 Received: August 8, 2016
Dear Mr. de van der Schueren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161324
Device Name Raycell Mk2
Indications for Use (Describe)
The Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease according to applicable FDA, AABB, Health Canada, and European guidelines.
The Raycell X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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510(k) SUMMARY
| Date Summary Prepared | May 6, 2016 |
|---|---|
| Submitted by | Best Theratronics |
| 413 March Road | |
| Ottawa, Ontario K2K 0E4 | |
| Canada | |
| Tel. (613) 591-2100 | |
| Fax. (613) 592-5680 | |
| Contact Person | Mr. Mike de van der Schueren |
| Quality & Regulatory Manager | |
| Trade Name | Raycell Mk2 |
| Common Name | Raycell X-Ray Blood Irradiator |
| Classification Name | Blood irradiators have not been classified |
| Legally Marketed Predicate Device | Raycell (K051065) |
| Device Classification | None |
| Product Code | 90 MOT |
Description of Device
The Raycell is a self-contained shielded cabinet X-Ray Blood Irradiator. The device consists of a lead shielded chamber containing two vertically opposed x-ray tubes with provision for a sample canister holder between them, dual power supplies and a operator control panel. The operator places the blood products to be irradiated in the canister, opens the drawer, places the canister in the holder, closes the drawer and starts the irradiation cycle at the Operator Panel. The design of this device is substantially equivalent to the predicate device.
Intended Use of Device
The Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease. This is the same intended use as previously cleared for the Raycell X-ray Blood Irradiator, (K051065).
The intended use of the modified device, as described in the labeling, has not changed as a result of the modifications.
Summary of Technological Characteristics
The Raycell is substantially equivalent to the predicate device (K051065).
The change to the Raycell design is to create a unit with increased capacity using the existing design. The same x-ray tubes and high voltage generators are used in the new Ravcell unit, but at a 25% higher power (4kW instead of 3.2kW on the predicate). There are no changes to the control system software from the predicate design.
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Following is a list of changes to the new design:
Canister Size
The new device is available in either a 3.5L sample canister configuration or a smaller 2L sample canister configuration. The predicate device was only available in a 1.5L configuration.
Sliding Drawer
A combination of a pivoting outer door and a hinged inner door was replaced by a sliding drawer arrangement. External radiation fields have been decreased and manufacturability aspects have been improved.
All electrical interlocks have been maintained. A new electro-mechanical safety interlock has been added, which prevents operators from opening the sample drawer when x-rays are generated. This was done to compensate for elimination of the outer door present in the previous design.
Shielded Irradiation Chamber
The volume inside the lead shielded chamber has increased to accommodate the 3.5L sample canister. The chamber has also been modified using the same lead shielding to improve manufacturability and access for service and maintenance. New access panels have been added and are interlocked electro-mechanically (same as predicate device). External radiation fields have decreased from the predicate design.
Digital Traceability
Optional digital traceability is available as a database to be used with the Raycell to eliminate the need for manually recording data and reducing human error. This consists of a bar code reader to record and store data from the blood baq and view it on a separate touch screen computer. It is able to retrieve cycle times from the Raycell, which allows the user to keep a history of the radiation cycles completed. It has no impact on radiation times or dose delivered and is not useable as a stand-alone product.
It is not intended to determine the suitability of donors and/or the release of blood or blood components for transfusion or further manufacture.
It does not change the intended use of the previously cleared Raycell X-ray Blood Irradiator.
Safety & Effectiveness
The safety of the Raycell is equivalent or better than the predicate device.
In terms of safety, the Raycell is designed to comply with
- . IEC 60601-1-2: Edition 3.0 2007-03 Medical electrical equipment – Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (Appendix L)
- . IEC 60601-1: Edition 3.0 2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Appendix M)
The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment. Validation testing demonstrated that the device is as safe and effective as the predicate device.